Synchronized eating for bipolar depression
Feasibility and Acceptability of Adjunctive Time Restricted Eating in Bipolar Disorder: A Pilot Randomized Controlled Trial.
This trial will test whether limiting eating to a 10-hour daily window plus usual care helps adults aged 18–55 with bipolar depression compared with nutritional counselling plus usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Ottawa Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06560957 on ClinicalTrials.gov |
What this trial studies
This pilot randomized trial will compare adjunctive 10-hour time-restricted eating (TRE) plus usual care to nutritional counselling plus usual care in adults with bipolar depression. The investigators aim to recruit 40 participants aged 18–55 with bipolar I or II disorder and current depressive symptoms, with an 18-month enrollment window and a target retention of at least 70%. Primary outcomes are feasibility and acceptability, measured as willingness to participate, dropout rates, and adherence to the assigned intervention; secondary measures will explore mood, metabolic, circadian, and cognitive outcomes. Results will inform the design of a future multi-centre randomized controlled trial if TRE appears feasible and acceptable.
Who should consider this trial
Good fit: Adults 18–55 with a confirmed diagnosis of bipolar I or II disorder who are currently depressed (MADRS ≥12 and YMRS ≤12), able to consent, and willing to follow the dietary timing intervention are ideal candidates.
Not a fit: People with current eating disorders or catatonia, unstable or inadequately treated medical/neurological conditions, prior bariatric surgery, pregnancy or lactation, or those taking hypoglycemia-inducing medications or stimulants are excluded and may not benefit from this intervention.
Why it matters
Potential benefit: If successful, TRE could improve depressive symptoms, stabilize circadian rhythms, and reduce metabolic side effects in people with bipolar disorder.
How similar studies have performed: Time-restricted eating has shown promising metabolic and circadian benefits in other populations, but it has not previously been tested in bipolar disorder or other mood disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be 18-55 years old 2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5. 3. Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS. 4. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\* 5. Participants must be able to speak, read, write and understand English or French. 6. Be willing and able to provide informed consent. Exclusion Criteria: 1. Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5. 2. Have any unstable or inadequately treated neurological and medical conditions. 3. Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications. 5\. Be pregnant or lactating. 6. Currently taking any stimulant medications. 7. Be participating in any other diet or weight management program for the duration of the trial. 8\. Have any contraindication to fasting as judged by the assessing clinician. 9. Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy). 10\. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.
Where this trial is running
Ottawa, Ontario
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Gayatri Saraf, MD — The Ottawa Hospital
- Study coordinator: Deniz Ruscuklu, BA
- Email: deruscuklu@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.